Soft anchor assembly with barbed flexible strand and techniques for use

ABSTRACT

A soft anchor assembly according to an exemplary aspect of the present disclosure includes, among other things, a sheath and a flexible strand at least partially surrounded by the sheath.

BACKGROUND

This disclosure relates to a surgical device and methods of using thesurgical device to attach body tissue, such as soft or hard tissue, toanother piece of body tissue. More particularly, this disclosure isdirected to a soft anchor assembly that includes a sheath and a barbedflexible strand at least partially extending through the sheath.

Orthopedic procedures are often performed to repair musculoskeletalinjuries. For example, soft tissue may tear away from bone duringvigorous exercise or sporting activities. When such tears occur,reattachment is often necessary to repair the damaged tissue. Sutureanchors are one type of surgical device that has been developed tofacilitate these repairs. Additional advancements in this field oftechnology are desired.

SUMMARY

A soft anchor assembly according to an exemplary aspect of the presentdisclosure includes, among other things, a sheath and a flexible strandat least partially surrounded by the sheath.

A soft anchor assembly according to another exemplary aspect of thepresent disclosure includes, among other things, at least one sheath anda flexible strand at least partially surrounded by the at least onesheath. The flexible strand includes a first plurality of barbsextending from the flexible strand.

A method according to another exemplary aspect of the present disclosureincludes, among other things, attaching a first piece of body tissue toa second piece of body tissue. The attaching step includes the use of asoft anchor assembly having at least one sheath that at least partiallysurrounds a flexible strand having a first plurality of barbs allowingmovement of the at least one sheath along said flexible strand in afirst direction and restricting movement of the at least one sheath in asecond direction.

A method according to another exemplary aspect of the present disclosureincludes, among other things, attaching a first piece of body tissue toa second piece of body tissue. The attaching step includes engaging thefirst piece of body tissue with the flexible strand having a firstplurality of barbs adjacent a first end and a second plurality of barbsadjacent a second end. The first end and the second end of the flexiblestrand are passed through at least one sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a soft anchor assembly according to a firstembodiment of this disclosure.

FIGS. 2A, 2B, and 2C illustrate a method of attaching pieces of bodytissue using the soft anchor assembly according to the first embodimentof the disclosure.

FIGS. 3A, 3B and 3C illustrate a soft anchor assembly according to asecond embodiment of this disclosure and a method of attaching pieces ofbody tissue using the soft anchor assembly according to the secondembodiment of the disclosure.

FIG. 4A illustrates a soft anchor assembly according to a thirdembodiment of this disclosure.

FIGS. 4B and 4C illustrate a method of attaching pieces of body tissueusing the soft anchor assembly according to the third embodiment of thedisclosure.

DETAILED DESCRIPTION

This disclosure describes various soft anchor assemblies and associatedsurgical techniques for attaching body tissue to body tissue. The softanchor assemblies are formed of “soft” materials, such as suturematerials, that confer the ability to be inserted into bonesockets/holes and bunch together, collapse, expand and/or change shapeto fixate within or adjacent the socket/hole. In some embodiments, thesoft anchor assembly includes a sheath at least partially surrounding aflexible strand. In other embodiments, the soft anchor assembly includesmultiple sheaths at least partially surrounding the flexible strand. Thesoft anchor assemblies of this disclosure may be utilized in varioussurgical techniques to attach body tissue to other body tissue. In theillustrated non-limiting embodiments, the body tissue could include softor hard tissue. These and other features are described in greater detailin the following paragraphs of this detailed description.

FIG. 1 illustrates a soft anchor assembly 10. The soft anchor assembly10 is configured for use in various soft tissue repairs or fixations.For example, the soft anchor assembly 10 can be used in conjunction witha variety of orthopedic surgical repairs, including but not limited torotator cuff repairs, Achilles tendon repairs, patellar tendon repairs,ACL/PCL reconstructions, hip and shoulder reconstructions, meniscalrepairs, among many others.

In this disclosure, the soft anchor assembly 10 is referred to as a“soft” construct because it is formed of soft materials such as yarns,fibers, filaments, strings, fibrils, strands, sutures, etc., or anycombination of such materials. The soft materials may be synthetic ornatural materials, or combinations of synthetic and natural materials,and may be bio-degradable or non-degradable within the scope of thisdisclosure. In one non-limiting embodiment, the soft anchor assembly 10is made exclusively of soft, suture-based materials.

The soft anchor assembly 10 may include at least two sheaths 12 and oneflexible strand 14. The sheaths 12 include a tubular body 16 extendingbetween opposing ends 18 a, 18 b. The opposing ends 18 a, 18 b may beopen or closed ends. The tubular body 16 establishes a bore 20 thatextends between the opposing ends 18 a, 18 b.

In one embodiment, the sheath 12 is a tubular sleeve made of a flexiblematerial, such as a braided, woven, or knitted structure made of yams,fibers, filaments, sutures or similar materials, or combinations ofthese materials. In another non-limiting embodiment, the sheath 12 isconstructed of polyester suture material. Other materials may also besuitable to construct the sheath 12.

The flexible strand 14 is passed through at least a portion of the bore20 of the sheath 12. The flexible strand 14 may assist in bunchingtogether the sheaths 12 once the soft anchor assembly 10 is inserted atleast partially into or through body tissue. In one embodiment, theflexible strand 14 passes through openings 22 formed through the tubularbody 16. In the illustrated non-limiting embodiment, the openings 22 arespaced inward from the opposing ends 18 a, 18 b of the sheath 12. Inanother non-limiting embodiment, the openings 22 are located in theopposing ends 18 a, 18 b of the sheath 12. The flexible strand 14 may beof any length and includes a first end 32 a and a second end 32 b thatextend outside of the sheath 12. This configuration can be used if theopposing ends 18 a, 18 b are open or closed ends.

In one embodiment, the flexible strand 14 is a suture and includes afirst plurality of barbs 24 a and a second plurality of barbs 24 bseparated by a central region 26 without any barbs. The first pluralityof barbs 24 a and the second plurality of barbs 24 b extend in an inwarddirection such that the sheath 12 is allowed to move inward towards thecentral region 26 and restricted from moving outward toward acorresponding one of the first and second ends 32 a, 32 b. Although thefirst and second plurality of barbs 24 a, 24 b are shown on opposingaxial sides of the flexible strand 14, the first and second plurality ofbarbs 24 a, 24 b could be located on only one side of the flexiblestrand 14, spiral around an exterior of the flexible strand 14, or be inanother configuration on the exterior of the flexible strand 14.

FIGS. 2A-2C schematically illustrate an exemplary method for attaching afirst piece of body tissue 28 a separated from a second piece of bodytissue 28 b by a tear 29 with the soft anchor assembly 10. Although theillustrated non-limiting embodiment shows the first and second pieces ofbody tissue 28 a, 28 b as being soft body tissue, the first and secondpieces of body tissue 28 a, 28 b could also include a combination ofsoft tissue and hard tissue or two pieces of hard tissue. Additionally,the first piece of body tissue 28 a and the second piece of body tissue28 b could part of a single piece of body tissue with the first andsecond pieces of body tissue 28 a, 28 b being portions of the singlepiece of body tissue located on opposite sides of the tear 29, such aswith a torn meniscus.

First, as shown in FIG. 2A, the first piece of body tissue 28 a isbrought into relative close proximity with the second piece of bodytissue 28 b. One of the sheaths 12 surrounding the flexible strand 14 isplaced within an opening 34 a in a penetrating pusher tool 34 andaligned with the first piece of body tissue 28 a. Once aligned with thefirst piece of body tissue 28 a, the penetrating pusher tool 34 ispassed through the first piece of body tissue 28 a to locate the sheath12 on an opposite side of the first piece of body tissue 28 a. A similarprocedure is followed with the penetrating pusher tool 34 to locate theother sheath 12 on an opposite side of the second piece of body tissue28 b.

The sheaths 12 surrounding the flexible strand 14 may be passed throughthe first and second pieces of body tissue 28 a, 28 b sequentially orsimultaneously with the use of a second penetrating pusher tool 34 (notshown).

As shown in FIG. 2B, once the sheaths 12 have passed through acorresponding one of the first and second pieces of body tissue 28 a, 28b, the flexible strand 14 is oriented with the central region 26 locatedin contact or in proximity to the tear 29 in the first and second piecesof body tissue 28 a, 28 b. The sheaths 12 are located on an oppositeside of the first and second pieces of body tissue 28 a, 28 b from thecentral region 26 of the flexible strand 14.

As shown in FIG. 2C, the spacing between the tear 29 forming the firstand second pieces of body tissue 28 a, 28 b is reduced by pulling thefirst end 32 a of the flexible strand 14 relative to the first piece ofbody tissue 28 a in the direction P1 and pulling the second end 32 b ofthe flexible strand 14 relative to the second piece of body tissue 28 bin the direction P2. Because the first and second plurality of barbs 24a, 24 b angle inward, the first and second ends 32 a and 32 b of theflexible strand 14 are able to be pulled through the first and secondpiece of body tissue 28 a, 28 b, in the directions P1, P2. The first andsecond plurality of barbs 24 a, 24 b prevent the flexible strand 14 fromretracting back through the first and second pieces of body tissue 28 a,28 b once pulled in the directions P1 and P2, respectively.

Any excess length on the flexible strand 14 can be trimmed so that thefirst and second ends 32 a, 32 b of the flexible strand 14 would beflush with the first and second pieces of body tissue 28 a, 28 b, ifdesired. The first and second plurality of barbs 24 a, 24 b on theflexible stand 14 allow for knotless tissue fixation which would not bepossible with the use of traditional barbless sutures.

FIGS. 3A-3B illustrate a second non-limiting embodiment of a soft anchorassembly 110 that is similar to the soft anchor assembly 10 shown inFIG. 1 except as otherwise described below or shown in the Figures. Theanchor assembly 110 includes at least one sheath 112 and the flexiblestrand 14 from the soft anchor assembly 10.

First, as shown in FIG. 3A, the flexible strand 14 is positionedrelative to a first piece of body tissue 128 a. In one non-limitingembodiment, the flexible strand 14 can wrap around the first piece ofbody tissue 128 a such that an exterior of the flexible strand 14contacts an exterior portion of the first piece of body tissue 128 a asshown in FIG. 3A. In another non-limiting embodiment, the flexiblestrand 14 can be threaded through the first piece of body tissue 128 asuch that the central region 26 of the flexible strand 14 is alignedwith the first piece of body tissue 128 a. Alternatively, the centralregion 26 is spaced from the first piece of body tissue 128 a and aportion of the flexible strand 14 including the first or secondplurality of bards 24 a, 24 b is located within the first piece of bodytissue 128 a. In the illustrated non-limiting embodiment, the firstpiece of body tissue 128 a is soft tissue and a second piece of bodytissue 128 b, shown in FIG. 3B, is hard tissue, such as bone.

The sheath 112 includes a tubular body 116 that extends between opposingends 118 a, 118 b. The tubular body 116 establishes a bore 120 thatextends between the opposing ends 118 a, 118 b. The opposing ends 118 a,118 b of the sheath 112 are open to allow the flexible strand 14 toenter and exit the sheath 112 at the opposing ends 118 a, 118 b.

Once the flexible strand 14 has been positioned relative to the firstpiece of body tissue 128 a, the first and second ends 32 a, 32 b of theflexible strand 14 are threaded through the openings in the opposingends 118 a, 118 b in the sheath 112 such that the first plurality ofbarbs 24 a overlap the second plurality of barbs 24 b in the sheath 112.In another non-limiting embodiment, the first and second ends 32 a, 32 bof the flexible strand 14 are threaded through openings formed in thetubular body 116 spaced inward from the opposing ends 118 a, 118 bsimilar to the openings 22 in the sheath 12 shown in FIG. 1.

Because the first and second plurality of barbs 24 a, 24 b are bothangled inward toward the central region 26, the first and secondplurality of barbs 24 a, 24 b will slide past each other when the firstand second ends 32 a, 32 b of the flexible strand 14 are pulled outwardthrough the sheath 112. Pulling the first and second ends 32 a, 32 b ofthe flexible strand 14 in the directions P1, P2, respectively, willreduce the size of a loop 115 formed by the flexible strand 14. Thefirst and second plurality of barbs 24 a, 24 b will restrict the loop115 formed by the flexible strand 14 from expanding in size because thefirst and second plurality of barbs 24 a, 24 b will engage each otherand restrict movement.

Referring to FIG. 3B, an opening 129 is formed in the second piece ofbody tissue 128 b with a tool, such as a punch or a drill. The sheath112 with the flexible strand 14 can then be placed within the opening129 with a suitable tool to ensure that the sheath 112 and the flexiblestrand 14 are inserted in the opening 129. Inserting the sheath 112 andthe flexible strand 14 in the opening 129 will secure the first piece ofbody tissue 128 a relative to the second piece of body tissue 128 b.Alternatively, the opening 129 is formed during insertion of the sheath112 and the flexible strand 14 into the second piece of body tissue 128b.

The first and second ends 32 a, 32 b of the flexible strand 14 aretensioned in the directions P1, P2, respectively, to lodge the anchorassembly 110 into the opening 129 to position the first piece of bodytissue 128 a relative to the second piece of body tissue 128 b. Thesheath 112 will bunch up and form a random pattern during lodging and/ortensioning, as shown in FIG. 3C. Any excess length on the flexiblestrand 14 can be trimmed to be flush with the second piece of bodytissue 128 b, if desired.

FIGS. 4A-4C illustrate yet another non-limiting embodiment of a softanchor assembly 210 that is similar to the soft anchor assembly 10 shownin FIG. 1 except as otherwise described below or shown in the Figures.The anchor assembly 210 includes multiple sheaths 12 and a flexiblestrand 214.

The flexible strand 214 includes a loop 215 on a first end 232 a passingthrough at least a portion of the bore 20 of the sheath 12. In order forthe sheath 12 to be installed on the loop 215, the sheath 12 could beattached to the first end 232 a of the flexible strand 214 before theloop 215 is formed. Alternatively, the sheath 12 could be separatedalong its axial length and then placed around the loop 215 and closed bystitching or another type of fastening, such as adhesive, depending onthe material of the sheath 12, among other factors.

In one embodiment, the flexible strand 214 is a suture and includesbarbs 224 extending along a length of the flexible strand 214 from theloop 215 to a second end 232 b. The barbs 224 extend towards the loop215 on the first end 232 a. The barbs 224 allow each sheath 12 to slidealong the flexible strand 214 from the second end 232 b towards to loop215 on the first end 232 a and restrict each sheath 12 from sliding fromthe first end 232 a toward the second end 232 b along the flexiblestrand 214. Although the barbs 224 are shown on opposing sides of theflexible strand 214, the barbs 224 could be located on only one side ofthe flexible strand 214, spiral around an exterior surface of theflexible strand 214, or be in another configuration as long as the barbs224 are angled toward the loop 215 on the first end 232 a.

As shown in FIG. 4B, the loop 215 on the flexible strand 214 surroundedby the sheath 12 is placed near a mid-portion of the first piece of bodytissue 28 a with the penetrating pusher tool 34 (FIG. 2A). The sheath 12next in line along the flexible strand 214 is then placed near amid-portion of the second piece of body tissue 28 b with the penetratingpusher tool 34 in a similar fashion. The remaining sheaths 12 on theflexible strand 214 are placed in an alternating pattern in the firstand second pieces of body tissue 28 a, 28 b such that adjacent sheaths12 are in alternating first and second pieces of body tissue 28 a, 28 b.Although five sheaths 12 are shown in the illustrated non-limitingembodiment, more or less than five sheaths 12 could be used to securethe first and second pieces of body tissue 28 a, 28 b together.

As shown in FIG. 4C, once all of the sheaths 12 have been lodged in thefirst and second pieces of body tissue 28 a, 28 b, the second end 232 bof the flexible strand 214 is pulled in a direction P3 to tighten thefirst and second pieces of body tissue 28 a, 28 b together. Because thebarbs 224 are angled toward the loop 215, the flexible strand 214 isable to be pulled through the first and second pieces of body tissue 28a, 28 b in the direction P3. The barbs 224 prevent the flexible strand214 from retracting back through the first and second pieces of bodytissue 28 a, 28 b once pulled in the direction P3. Any excess flexiblestrand 214 can be trimmed so that the second end 232 b of the flexiblestrand 214 would be flush with either the first or second pieces of bodytissue 28 a, 28 b, if desired.

The anchor assembly of this disclosure provides an improved knotlesstechnique to simplify and improve body tissue fixation. The barbs on theflexible strand grab and engage the sheaths with greater repeatabilityand provide stronger attachment to tissue than traditional sutureswithout barbs.

Although the different non-limiting embodiments are illustrated ashaving specific components, the embodiments of this disclosure are notlimited to those particular combinations. It is possible to use some ofthe components or features from any of the non-limiting embodiments incombination with features or components from any of the othernon-limiting embodiments.

It should be understood that like reference numerals identifycorresponding or similar elements throughout the several drawings. Itshould also be understood that although a particular componentarrangement is disclosed and illustrated in these non-limitingembodiments, other arrangements could also benefit from the teachings ofthis disclosure.

The foregoing description shall be interpreted as illustrative and notin any limiting sense. A worker of ordinary skill in the art wouldunderstand that certain modifications could come within the scope ofthis disclosure. For these reasons, the following claims should bestudied to determine the true scope and content of this disclosure.

What is claimed is:
 1. A soft anchor assembly, comprising: at least onesheath; and a flexible strand passing through said at least one sheath,said flexible strand including a first plurality of barbs.
 2. Theassembly as recited in claim 1, wherein said at least one sheath is atubular sleeve made of a flexible material.
 3. The assembly of claim 1,wherein said first plurality of barbs restrict movement of said at leastone sheath in a first direction and allow movement of said at least onesheath in a second opposite direction.
 4. The assembly of claim 3,wherein said flexible strand includes a second plurality of barbs thatrestricts movement of a second sheath of said at least one sheath insaid second direction and allows movement of said second sheath in saidfirst direction.
 5. The assembly of claim 4, wherein said flexiblestrand includes a central region separating said first plurality ofbarbs from said second plurality of barbs and said first plurality ofbarbs and said second plurality of barbs are angled toward said centralregion.
 6. The assembly of claim 4, wherein said first plurality ofbarbs are located adjacent a first end of said flexible strand and saidsecond plurality of barbs are located adjacent a second opposite end ofsaid flexible strand.
 7. The assembly of claim 1, wherein said flexiblestrand forms a loop and includes a second plurality of barbs, said firstplurality of barbs and said second plurality of barbs are threadedthrough said at least one sheath such that said first plurality of barbsoverlap said second plurality of barbs within said at least one sheath.8. The assembly of claim 3, wherein a first end of said flexible strandforms a loop at least partially surrounded by one of said at least onesheath.
 9. The assembly of claim 8, wherein said first plurality ofbarbs extend from said loop to a second end of said flexible strand andare angled toward said loop.
 10. The assembly of claim 8, wherein saidat least one sheath includes a tubular body defining a bore and saidflexible strand extends through said tubular body.
 11. A method,comprising: attaching a first portion of body tissue to a second portionof body tissue, said attaching step including: utilizing a soft anchorassembly having a flexible strand passing through at least one sheath,said flexible strand having a first plurality of barbs allowing movementof said at least one sheath along said flexible strand in a firstdirection and restricting movement of said at least one sheath in asecond direction.
 12. The method of claim 11, wherein said attachingstep includes: inserting one of said at least one sheath at leastpartially through a first portion of body tissue; and inserting anotherone of said at least one sheath at least partially through a secondportion of body tissue.
 13. The method of claim 12, wherein said firstplurality of barbs allow said flexible strand to pass through said firstportion of body tissue in a first direction and restrict said flexiblestrand from passing through said first portion of body tissue in asecond direction.
 14. The method of claim 13, wherein said flexiblestrand includes a second plurality of barbs that allow said flexiblestrand to pass through said second portion of body tissue in said seconddirection and restrict said flexible strand from passing through saidsecond portion of body tissue in said first direction.
 15. The method ofclaim 11, wherein the first portion of body tissue and the secondportion of body tissue are on opposite sides of a tear in a single pieceof body tissue.
 16. A method, comprising: engaging a first piece of bodytissue with a flexible strand, said flexible strand including a firstplurality of barbs adjacent a first end and a second plurality of barbsadjacent a second end; and passing said first end and said second end ofsaid flexible strand through at least one sheath.
 17. The method ofclaim 16, comprising: inserting said at last one sheath at leastpartially through a second piece of body tissue, wherein said firstpiece of body tissue is soft body tissue and said second piece of bodytissue is hard body tissue.
 18. The method of claim 17, comprising:tensioning said first end and said second end of said flexible strand toposition said first piece of body tissue relative to said second pieceof body tissue.
 19. The method of claim 17, wherein said first pluralityof barbs and said second plurality of barbs on said flexible strand arethreaded through said at least one sheath such that said first pluralityof barbs overlap said second plurality of barbs inside said at least onesheath and said flexible strand forms a loop.
 20. The method of claim19, wherein said first plurality of barbs and said second plurality ofbarbs allow said loop to be tightened but restrict said loop from beingloosened.